口服太景奈諾沙星 授權浙江醫藥集團

TaiGen expects Chinese, local go-ahead for drug Fri, May 17, 2013 -By Camaron Kao Local drug maker TaiGen Biotechnology Co (太景生技) yesterday said that it expected to get permission from Chinese and Taiwanese health authorities to sell its new pneumonia drug in the first half of next year. TaiGen's oral formulation of nemonoxacin, an antibiotic, is used to cure community-acquired pneumonia, and might also prove effective in curing other diseases, such as diabetic foot, the company said. The oral formulation of nemonoxacin was the first drug to be tested under the cross-strait Economic Cooperation Framework Agreement's (ECFA) cooperation pact on medicine, which expedites the approval process by allowing TaiGen to conduct clinical trials in both Taiwan and China, and to submit applications to both governments using the same document. "The large and fast-growing medical market in China can no longer be overlooked, which is the reason we tried to make use of the pact," TaiGen CEO and chairman Hsu Ming-chu (許明珠) said at a press conference yesterday. The market for both oral and intravenous formulations of nemonoxacin in China could amount to about 1 billion yuan (NT$4.88 billion) a year, the company said.

FIRST FOR TAIWAN TaiGen's drug is likely to be the first drug from Taiwan to meet the requirements to be registered as a category 1.1 new drug in China, and would enjoy a higher price premium, which was an incentive given by the Chinese government to encourage new drugs to debut in the country, Hsu said. The oral formulation of nemo-noxacin was licensed to China-based Zhejiang Medicine Co (浙江醫藥集團) — which will be responsible for the marketing and manufacturing of the drug in China — for US$8 million and royalties of 7 percent to 11 percent on future sales of the drug.

TRIALS The intravenous formulation of nemonoxacin is still in the second stage of clinical trials in China and Taiwan, TaiGen said. Compared with existing drugs, nemonoxacin can minimize side effects and reduce the possibility of developing resistance to the drug, Hsu said. Meanwhile, the Cayman Island-based company said it plans to launch an initial public offering in Taiwan by issuing 634 million shares on its Emerging Stock Market (興櫃市場) early next month. It is scheduled to move to the more active GRETAI Securities Market by the end of this year.